DESCRIPTION: (Applicant's Description) The goals of the Biostatistics and Data Management Core are to provide statistics and data management services to support research conducted by the project investigators. Core members include biostatisticians and data management and computing professionals from the Department of Biostatistics and Epidemiology and Center for Clinical Epidemiology and Biostatistics at Penn. Dr. Kathleen Joy Propert, Assistant Professor of Biostatistics, will serve as the Core Director overseeing all activities and personnel. The specific aims of the Biostatistics and Data Management Core are: (1) Biostatistics: (a) Advise investigators on study design issues for clinical protocols, animal studies, and other research. (b) Conduct interim analyses and assist with writing of interim reports as required for data and safety monitoring of clinical protocols. (c) Conduct statistical analyses of data from clinical and laboratory projects to address specific research hypotheses as defined in the project-specific proposals. (d) Assist with preparation for and writing of final reports, abstracts, manuscripts, and future research proposals. (e) Conduct exploratory analyses that may lead to generation of new hypotheses. (2) Data Management: (a) Implement a framework to facilitate data management and statistical analysis for all projects by establishing interaction among biostatisticians, data management specialists, computing and database personnel, and project investigators. (b) Design and implement procedures for enrolling patients to clinical projects and tracking the flow of data through various study phases. (c) Develop and implement procedures for case report forms design and coding, data entry and validation, quality assurance, and reporting. (d) Design, test, implement, and maintain database structures and application programs to support Aims 2b and 2c.